(4) specific approval varieties kinds analysis
From the registration data, in vitro diagnostic reagents in registered products accounted for more than major, among them, the class iii medical devices within the boundaries, in vitro diagnostic reagents registrations accounted for 43% of all registered number, import medical devices, in vitro diagnostic reagents registrations accounted for 33% of the total registered number.
In 2016, registered in the third class medical apparatus and instruments, in addition to in vitro diagnostic reagent, involved in the catalog of medical device classification 28 subdirectory.
Registration number of the top five in class iii medical devices: implant materials and artificial organs, medical polymer materials and products, injection puncture instrument, medical optical instruments, instruments and endoscope equipment, operating room, emergency room, the doctor's office equipment and apparatus.
Compared with 2015, implanted materials and artificial organs from the second to the first class products, the operating room, emergency room, the doctor's office equipment and appliance replaced the intervention equipment in the top five.
Figure 11. In the third class medical device registration varieties figure of qualifying
In 2016, the registration of import medical instrument, in addition to in vitro diagnostic reagent, involved in the catalog of medical device classification 39 subdirectory.
Registration number of the top five imported medical instruments, mainly: implant materials and artificial organs, medical optical instruments, instruments and endoscope equipment, medical electronic equipment, medical polymer materials and products, the operating room, emergency room, the doctor's office equipment and apparatus.
Compared with 2015, the same is implanted materials and artificial organs from the second to the first class products, the operating room, emergency room, the doctor's office equipment and appliance replace kouqiangke materials in the top five.
Figure 12. Varieties of imported medical device registration qualifying figure
(5) import medical equipment national analysis
In 2016, the United States, Germany, Japan, Britain and south Korean medical devices in China medical device registration number row of the top five, is the same with 2015, accounting for about 2016 registered 73% of the total number of imported products.
Figure 13. Imported medical equipment national registered qualifying figure
(6) class iii medical devices within the territory of province analysis
From 2016, the third class medical device registration in the relevant registry product production enterprise mainly concentrated in the coastal economy more developed provinces.
Figure 14. Class iii medical devices province registered within the territory of distribution
Among them, Beijing, jiangsu, Shanghai, guangdong, zhejiang is in the third class medical device registration number of the top five provinces, accounting for 2016 69% of the registered number of the class iii medical devices in China.
Figure 15. Provinces within the territory of the third class medical device registration qualifying figure
Four, innovative medical equipment and other products for examination and approval of the review
In 2016, the food and drug supervision bureau according to "innovation medical instrument special approval procedures (trial)", continue to do a good job in innovative medical devices to review and approve the listed part of innovation of medical equipment products.
In 2016, the food and drug supervision bureau received 197 innovative medical devices for examination and approval of special application, organize experts to review project 175, completed 144 review application items (including 2015), determine the 45 products into the innovation of medical equipment for examination and approval of special channel. Approved registration three-dimensional cardiac electrophysiological measurement system and so on 10 products listed. Among them, the active medical equipment 6, passive medical equipment item 3, 1 item of in vitro diagnostic reagents. Compared with the 2015 total 1 item.
These innovative products core technology has China's invention patent or patent application for invention has public administrative department for patent under the state council, the products are mainly working principle/mechanism for domestic initiative, has significant clinical value.
(a) 3 d cardiac electrophysiology standard measurement system (the machinery note 20163770387, Shanghai minimally invasive electrophysiological medical technology co., LTD.). The product is based on the catheter on atrial and ventricular electrophysiology standard of measuring and locating system, with cold saline infusion radiofrequency ablation catheters and surface reference electrode used in combination, through collection and analysis of cardiac electrophysiological activity, can real-time display the human body heart 3 d graphics.
(2) of the respiratory tract pathogen nucleic acid detection kit (thermostatic expansion chip method) (the machinery note 20163400327, Po the biological group co., LTD.). The product is used for the qualitative detection of sputum in eight kinds of clinical common lower respiratory pathogens, including: streptococcus pneumoniae, staphylococcus aureus, methicillin-resistant staphylococcus aureus, klebsiella pneumoniae, pseudomonas aeruginosa, acinetobacter baumannii, eosinophilic malt narrow food, flu bloodthirsty bacillus bacterium.
Implantable vagus nerve stimulation (3) pulse generator kit (China machinery note 20163210989, chi medical equipment co., LTD., Beijing), implantable vagus nerve stimulation electrode wire suite (China machinery note 20163210990, chi medical equipment co., LTD., Beijing). "Implantable vagus nerve stimulation pulse generator kit" by the pulse generator, test the resistance, torque screwdriver, and control the magnet. "Implantable vagus nerve stimulation electrode wire suite" by the electrode, making tunnel tools (including piercing tools and casing) and clamp. The above two products, the drug can not effectively control the can have the effect of control seizures in patients with refractory epilepsy. Vagus nerve stimulation is the first domestic product for the treatment of epilepsy.
(4) drug-eluting peripheral catheter balloon expansion (China machinery note 20163771020, Beijing first rita medical technology co., LTD.). For OTW catheter balloon expansion, the product by the balloon catheter tips, shaft rod and other components, and coated with silicone lubrication coating. The product is suitable for femoral and popliteal artery angioplasty (PTA) in the bellows.
(5) cold saline infusion radiofrequency ablation catheter (China machinery note 20163771040, Shanghai minimally invasive electrophysiological medical technology co., LTD.). This product is designed for intracardiac electrophysiology standard measurement based on catheter, the product can be compatible with ColumbusTM three-dimensional cardiac electrophysiology standard reference electrode, measuring system and the body surface to provide location information; When used with radiofrequency ablation instrument, can be used for the treatment of drug refractory persistent af.
(6) chest plate (the machinery note 20163461582, changzhou Watson medical instrument co., LTD.). This product is suitable for adult right in the middle of the sternum after internal fixation of the sternum. When used alone sternum fixture, at least use four sternum fixtures. If due to reasons such as sternal deformity can't use four sternum fixed device at the same time, to be used in combination with sternum silk and/or chest plate fixation.
(7) positron emission and X-ray computed tomography (ct) imaging device (the machinery note 20163332156, MingFeng medical system co., LTD.). This product combines X-ray computed tomography (CT) and positron emission computed tomography (PET) system, provide the physiological and anatomic information of registration and fusion. The product gamma photon localization precision, digital signal processing and sampling method is advanced, the generated image at the same time, including the functions of human organs and tissues or anatomical information, information can be used for tumor, brain diseases, and cardiovascular disease diagnosis, treatment and curative effect evaluation and so on.
Machinery (eight), intraocular lens (countries note 20163221747, aibo noble (Beijing) medical technology co., LTD.). High surface after the product has "convex", "high order aspheric", "complex surface form independent separation" and "edge thickness" and "hydrophobic with heparin modified acrylate material" wait for a characteristic, is the first in the domestic intraocular lens. Suitable for adults with no crystal eyes and vision correction of primary corneal astigmatism after remove cataracts, aimed at improving eyesight, reduce the residual powder luminosity and reduce dependence on far sight glasses.
(9) orthopaedic surgery navigation system (the machinery note 20163542280, Beijing days wisdom navigation medical technology co., LTD.). The product is used for the spine and trauma orthopaedics open or percutaneous surgery assisted by mechanical arm to complete surgical instruments or implant positioning. This product USES the six degrees of freedom mechanical arm, compatible with 2 d and 3 d medical image such as patent technology, each performance index has reached the international level, similar product is suitable for using orthopaedic trauma hollow screw fixation and spinal screw fixation of the patients, can effectively ensure the accuracy of screw placement, shorten the operation time, reduce the X-ray radiation damage, reduce the injury patients.
Food and drug supervision bureau in 2016 approved the part has good clinical application prospects of medical equipment product registration. Such as:
(1) of mycobacterium tuberculosis fluoroquinolone drugs resistant mutation detection kit (fluorescence PCR melting curve method) machinery must have 20163401457 injection (countries), mycobacterium tuberculosis streptomycin resistance mutation detection kit (fluorescence PCR melting curve method) machinery must have 20163401458 injection (countries), mycobacterium tuberculosis ethambutol resistant mutation detection kit (fluorescence PCR melting curve method) machinery must have 20163401459 injection (countries), the above three in-vitro diagnostic reagent products are manufactured by xiamen to good biological technology co., LTD., is the first approved domestic similar products, were used to detect mycobacterium tuberculosis of fluoroquinolone drugs resistance, resistance or ethambutol streptomycin drugs drug resistance, can be used for clinical auxiliary diagnosis of tuberculosis. The products listed, is conducive to timely diagnosis and treatment of mdr-tb patients, so as to better control and treatment of tuberculosis.
Succinyl acetone (2) and the derivative to many kinds of amino acids, carnitine assay kit (tandem mass spectrometry) machinery (countries note quasi 20163401324), a variety of amino acid derivatives and carnitine assay kit (tandem mass spectrometry) machinery must have 20163401325 injection (countries), both in vitro diagnostic reagent products are manufactured by guangzhou forword biological engineering co., LTD., is the first approved domestic similar products, were used to detect neonatal dried blood piece of filter paper samples in succinyl acetone, amino acids, carnitine concentration and detection of neonatal dried blood filter paper pieces of a variety of amino acids and carnitine concentration in the sample. In addition to the tandem mass spectrometry, the conventional laboratory method to detect the indexes of the product provides available methods for clinical diagnosis of hereditary metabolic disease.
(3) gene sequencing machine (the machinery note 20163402206, shenzhen genomics biomedical engineering co., LTD.). It adopts combined probe anchoring polymerization sequencing technology, clinically used to sample from human body of deoxyribonucleic acid (DNA) sequencing, to detect genetic changes, these genetic changes may lead to disease or susceptibility. The equipment is not used in the human genome sequencing or sequencing from scratch.
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